The world's second-largest drugmaker said Monday that its Xeljanz has been approved, for patients not adequately helped by existing treatments, in Russia, Argentina, Kuwait, the United Arab Emirates and Switzerland, the first European country to allow sales.
Xeljanz, the first in a new class of drugs for the joint-damaging immune disorder, was launched in November in the U.S., where it has been heavily advertised. It's about to be launched in Japan, where it was approved in March. But concerns over serious, though generally rare, side effects including cancer have blocked approval in Europe so far.
New York-based Pfizer has been hoping to win over patients who either just take pain relievers or are being treated with injected biologic drugs meant to slow or stop progression of moderate to severe rheumatoid arthritis. The biologic drugs, which are produced in living cells rather than by mixing chemicals together, include Enbrel, Humira and Remicade.
All three have been blockbusters for years, because they are approved for treating multiple immune disorders and are very pricey. Each was among the world's top six drugs by revenue last year, and their combined sales for all uses totalled about $23 billion.
According to Pfizer, the wholesale price for a month's supply of Xeljanz is about $2,055; the retail price likely would be higher. The three biologic drugs cost roughly $2,500 per month.
Humira is sold by AbbVie Inc., Remicade by Johnson & Johnson and Merck & Co., and Enbrel by Amgen Inc. and Pfizer.
Meanwhile, Pfizer is asking advisers to European Union medical regulators to reconsider their recommendation in April not to approve the drug.
The advisers said Xeljanz didn't control progression of the immune disorder enough to outweigh serious side effects seen in some patients. Those include blood and other cancers, perforated intestines, tuberculosis and other infections, decreased infection-fighting cells, headaches and diarrhea.
Nearly 24 million people worldwide suffer from rheumatoid arthritis, a painful, often disabling immune disorder. Many aren't satisfied with current treatments.
Linda A. Johnson can be followed at http://twitter.com/LindaJ_onPharma